Nonprescription Drugs Advisory Committee
The Safety of Phenylpropanolamine Hydrochloride (PPA) used in OTC Weight Control and Nasal Decongestant Drug Products
October 19, 2000
BACKGROUND PACKAGE 1 & 2 FOR NDAC REVIEW OF PPA/STROKE STUDY REPORT
Tab 1. THE PPA SAFETY ISSUE: Background Memo
Tab 6a. EPIDEMIOLOGIC REVIEW OF PPA SAFETY ISSUES 4/30/91: FDA Div. of Epidemiology and Surveillance
Tab 6b. ANALYSIS OF PPA AND HEMORRHAGIC STROKE 8/6/91: FDA Div. of Epidemiology and Surveillance
Tab 6c. SAFETY OF PPA FOR WEIGHT CONTOL DRUG 12/26/91: FDA Div. of Epidemiology and Surveillance
Tab 6e. CONCLUSIONS OF EPIDEMIOLOGY CONSULTANTS 7/92
Tab 6f. SUMMARY OF CONSULTANTS REVIEWS 10/5/92 FDA Div. of Epidemiology and Surveillance
Tab 6g. ADDITIONAL EPIDEMIOLOGY CONSULTANT COMMENTS 10/92
Tab 8. LETTER TO NDMA 3/9/93: FDA' S PPA Safety Concerns
Tab 9. LETTER TO NDMA 6/17/93: FDA'S Comments on Stroke Study Protocol
Tab 10. LETTER FROM NDMA 8/11/93: NDMA's Response to FDA Comments on Proposed Study Protocol
Tab 11. MEETING MINS: 8/25/93: Feedback Meeting on Study Protocol
Tab 12. NDMA RESPONSE TO 8/25 FEEDBACK MEETING 10/14/93
Tab 13. PPA/STROKE STUDY FINAL PROTOCOL 4 / 15 / 94
Tab 15. Weintraub et. al. "Phenylpropanolamine Oros vs. placebo in combination with Caloric restriction and physician-managed behavior modification," Clinical Pharmacology and Therapeutics, vol 39 (May 1986), , No. 5, 501-509 .*
Tab 16. Report by David Schteingart, "A Double Blind Clinical Evaluation of the norectic Activity Of Phenylpropanolamine (75mg) Compared with Placebo in the Treatment of Exogenous Obesity," Clinical Study Synopsis, December 1989.*
Tab 17. Report by Frank Greenwy, "A Double Blind Clinical Evaluation of the Anorectic Activity Of Phenylpropanolamine (75mg) Compared with Placebo in the Treatment of Exogenous Obesity," Clinical Study Synopsis, December 1989.*
Tab 18. Report by Richard Atkinson. "A Double Blind Clinical Evaluation of the Anorectic Activity Of Phenylpropanolamine (75mg) Compared with Placebo in the Treatment of Exogenous Obesity," Clinical Study Synopsis, December 1989.*
Tab 19. YALE HEMORRHAGIC STROKE PROJECT: Final Study Report .doc .pdf
FDA Background 3
Tab 1 - Epidemiological Review doc pdf
Spreadsheet xls
Tab 2 - Statistical Review doc pdf
Yale University response to the Consumer Healthcare Products Association Comment, dated September 19, 2000 doc pdf
Consumer Healthcare Products Association letter to Members of the FDA Nonprescriptions Drugs Advisory Committee, Dated September 21, 2000
Appendix B - CHPA Comments on the Hemorrhagic Stroke Project Report
Appendix C - May 1989 Submission on the Safety of Phenylpropanolamine as an OTC Ingredient
Appendix D - Epidemiologic Analysis (September 3, 1991)
*These documents contain copyrighted material. They may be viewed at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.